Systems and methods for electrically stimulating patient tissue on or around one or more bony structures

ABSTRACT

An implantable lead assembly for providing electrical stimulation to a patient includes a lead body; a terminal disposed along a proximal end of the lead body; and an orthopedic implant coupled to a distal end of the lead body. The orthopedic implant is configured and arranged for anchoring to a bony structure. At least one mounting region is disposed along the orthopedic implant. The at least one mounting region is configured and arranged for anchoring the orthopedic implant to the at least one bony structure. An electrode is disposed along a stimulation region of the orthopedic implant. A conductor electrically couples the terminal to the electrode.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/899,350 filed May 21, 2013 which claims the benefit under 35 U.S.C.§119(e) of U.S. Provisional Patent Application Ser. No. 61/651,840 filedon May 25, 2012, all of which are incorporated herein by reference.

FIELD

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to implantable electrical stimulationleads configured and arranged for anchoring to one or more bonystructures in proximity to a target stimulation region, as well asmethods of making and using the leads and electrical stimulationsystems.

BACKGROUND

Implantable electrical stimulation systems have proven therapeutic in avariety of diseases and disorders. For example, spinal cord stimulationsystems have been used as a therapeutic modality for the treatment ofchronic pain syndromes. Peripheral nerve stimulation has been used totreat incontinence, as well as a number of other applications underinvestigation. Functional electrical stimulation systems have beenapplied to restore some functionality to paralyzed extremities in spinalcord injury patients.

Stimulators have been developed to provide therapy for a variety oftreatments. A stimulator can include a control module (with a pulsegenerator), one or more leads, and an array of stimulator electrodes oneach lead. The stimulator electrodes are in contact with or near thenerves, muscles, or other tissue to be stimulated. The pulse generatorin the control module generates electrical pulses that are delivered bythe electrodes to body tissue.

Dorsal root ganglia are nodules of cell bodies disposed along the dorsalroots of spinal nerves. Dorsal root ganglia are disposed external to theepidural space. Dorsal root ganglia, however, are disposed in proximityto the spinal cord and the vertebral column.

BRIEF SUMMARY

In one embodiment, an implantable lead assembly for providing electricalstimulation to a patient includes a lead body having a proximal end, adistal end, and a longitudinal length; at least one terminal disposed atthe proximal end of the lead body; and an orthopedic implant coupled tothe distal end of the lead body. The orthopedic implant is configuredand arranged for anchoring to at least one bony structure. Theorthopedic implant includes an elongated orthopedic implant body havinga first end and an opposing second end. At least one mounting region isdisposed along the orthopedic implant body. The at least one mountingregion is configured and arranged for anchoring the orthopedic implantto the at least one bony structure. At least one stimulation region isdisposed along the orthopedic implant body. At least one electrode isdisposed along the at least one stimulation region. At least oneconductor electrically couples the at least one terminal to the at leastone electrode.

In another embodiment, a lead anchoring assembly for providingelectrical stimulation includes an orthopedic implant configured andarranged to receive a distal end of a lead body of a first lead. Theorthopedic implant is configured and arranged for anchoring to at leastone bony structure. The orthopedic implant includes an orthopedicimplant body having a first end, a second end opposite to the first end,a first side, a second side opposite to the first side, a top surface,and a bottom surface opposite to the top surface. At least one mountingregion is disposed along the first end of the orthopedic implant body.The at least one mounting region is configured and arranged foranchoring the orthopedic implant to the at least one bony structure. Alead anchoring region is disposed along the orthopedic implant body. Thelead anchoring region is configured and arranged for receiving the firstlead and for fastening the first lead to the orthopedic implant.

In yet another embodiment, an implantable lead assembly for providingelectrical stimulation to a patient includes a lead body having aproximal end, a distal end, and a longitudinal length; at least oneterminal disposed at the proximal end of the lead body; and anorthopedic implant coupled to the distal end of the lead body. Theorthopedic implant is configured and arranged for anchoring to at leastone bony structure. The orthopedic implant includes a head configuredand arranged for receiving a fastening tool. An elongated shaft iscoupled to the head. The shaft has a first end and an opposing secondend. The first end couples to the head. A tip is disposed on the secondend of the shaft. The tip is configured and arranged to anchor to the atleast one bony structure. At least one electrode is disposed along thetip of the orthopedic implant. At least one conductor electricallycouples the at least one terminal to the at least one electrode.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic view of one embodiment of an electricalstimulation system that includes a paddle body coupled to a controlmodule via lead bodies, according to the invention;

FIG. 2 is a schematic view of another embodiment of an electricalstimulation system that includes a percutaneous lead body coupled to acontrol module via a lead body, according to the invention;

FIG. 3A is a schematic view of one embodiment of a plurality ofconnector assemblies disposed in the control module of FIG. 1, theconnector assemblies configured and arranged to receive the proximalportions of the lead bodies of FIG. 1, according to the invention;

FIG. 3B is a schematic view of one embodiment of a connector assemblydisposed in the control module of FIG. 2, the connector assemblyconfigured and arranged to receive the proximal portion of one of thelead body of FIG. 2, according to the invention;

FIG. 3C is a schematic view of one embodiment of a proximal portion ofthe lead body of FIG. 2, a lead extension, and the control module ofFIG. 2, the lead extension configured and arranged to couple the leadbody to the control module, according to the invention;

FIG. 4A is a schematic transverse cross-sectional view of spinal nervesextending from a spinal cord, the spinal nerves including dorsal rootganglia;

FIG. 4B is a schematic perspective view of a portion of the spinal cordof FIG. 4A disposed in a portion of a vertebral column with the dorsalroot ganglia of FIG. 4A extending outward from the vertebral column;

FIG. 4C is a schematic top view of a portion of the spinal cord of FIG.4A disposed in a vertebral foramen defined in a vertebra of thevertebral column of FIG. 4B, the vertebra also defining intervertebralforamina extending between an outer surface of the vertebra and thevertebral foramen, the intervertebral foramina providing an openingthrough which the dorsal root ganglia of FIG. 4B can extend outward fromthe spinal cord of FIG. 4B;

FIG. 4D is a schematic side view of two vertebrae of the vertebralcolumn of FIG. 4B, the vertebrae defining an intervertebral foramenthrough which the dorsal root ganglia of FIG. 4B can extend outward fromthe spinal cord of FIG. 4B;

FIG. 5A is a schematic bottom view of one embodiment of an orthopedicimplant suitable for anchoring to one or more of the vertebrae of FIG.4B, according to the invention;

FIG. 5B is a schematic side view of one embodiment of the orthopedicimplant of FIG. 5A, according to the invention;

FIG. 5C is a schematic top view of one embodiment of the orthopedicimplant of FIG. 5A anchored to two of the vertebrae of FIG. 4B,according to the invention;

FIG. 5D is a schematic side view of one embodiment of the orthopedicimplant of FIG. 5A anchored to two of the vertebrae of FIG. 4B,according to the invention;

FIG. 6A is a schematic bottom view of a second embodiment of anorthopedic implant suitable for anchoring to one or more of thevertebrae of FIG. 4B, according to the invention;

FIG. 6B is a schematic side view of one embodiment of the orthopedicimplant of FIG. 6A, according to the invention;

FIG. 6C is a schematic top view of one embodiment of the orthopedicimplant of FIG. 6A anchored to two of the vertebrae of FIG. 4B,according to the invention;

FIG. 6D is a schematic side view of one embodiment of the orthopedicimplant of FIG. 6A anchored to two of the vertebrae of FIG. 4B,according to the invention;

FIG. 7A is a schematic bottom view of a third embodiment of anorthopedic implant suitable for anchoring to one or more of thevertebrae of FIG. 4B, according to the invention;

FIG. 7B is a schematic side view of one embodiment of the orthopedicimplant of FIG. 7A, according to the invention;

FIG. 7C is a schematic top view of one embodiment of the orthopedicimplant of FIG. 7A anchored to two of the vertebrae of FIG. 4B,according to the invention;

FIG. 7D is a schematic side view of one embodiment of the orthopedicimplant of FIG. 7A anchored to two of the vertebrae of FIG. 4B,according to the invention;

FIG. 8A is a schematic side view of a fourth embodiment of an orthopedicimplant suitable for anchoring to one of the vertebrae of FIG. 4B,according to the invention;

FIG. 8B is a schematic side view of one embodiment of the orthopedicimplant of FIG. 8A anchored to one of the vertebrae of FIG. 4B,according to the invention;

FIG. 8C is a schematic side view of another embodiment of the orthopedicimplant of FIG. 8A anchored to one of the vertebrae of FIG. 4B, theorthopedic implant having a bendable electrode, according to theinvention;

FIG. 8D is a schematic top view of one embodiment of the orthopedicimplant of FIG. 8C anchored to one of the vertebrae of FIG. 4B,according to the invention;

FIG. 9A is a schematic top view of a fifth embodiment of an orthopedicimplant that includes an anchoring unit suitable for anchoring one ormore leads to one or more of the vertebrae of FIG. 4B, according to theinvention;

FIG. 9B is a schematic side view of one embodiment of the orthopedicimplant of FIG. 9A, according to the invention;

FIG. 9C is a schematic top view of one embodiment of two percutaneousleads fastened to the orthopedic implant of FIG. 9A, according to theinvention;

FIG. 9D is a schematic top view of one embodiment of the twopercutaneous leads of FIG. 9C fastened to the orthopedic implant of FIG.9A, and the orthopedic implant anchored to two of the vertebrae of FIG.4B, according to the invention;

FIG. 9E is a schematic top view of one embodiment of a paddle leadfastened to the orthopedic implant of FIG. 9A, according to theinvention; and

FIG. 10 is a schematic overview of one embodiment of components of anelectrical stimulation system, according to the invention.

DETAILED DESCRIPTION

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to implantable electrical stimulationleads configured and arranged for anchoring to one or more bonystructures in proximity to a target stimulation region, as well asmethods of making and using the leads and electrical stimulationsystems.

Suitable implantable electrical stimulation systems include, but are notlimited to, an electrode lead (“lead”) with one or more electrodesdisposed on a distal end of the lead and one or more terminals disposedon one or more proximal ends of the lead. Leads include, for example,deep brain stimulation leads, percutaneous leads, paddle leads, and cuffleads. Examples of electrical stimulation systems with leads are foundin, for example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029;6,609,032; 6,741,892; 7,244,150; 7,672,734; 7,761,165; 7,949,395;7,974,706; 8,175,710; 8,224,450; and 8,364,278; and U.S. PatentApplication Publication No. 2007/0150036, all of which are incorporatedby reference.

FIG. 1 illustrates schematically one embodiment of an electricalstimulation system 100. The electrical stimulation system includes acontrol module (e.g., a stimulator or pulse generator) 102 and a lead103. The lead 103 including a paddle body 104 and one or more leadbodies 106 coupling the control module 102 to the paddle body 104. Thepaddle body 104 and the one or more lead bodies 106 form the lead 103.The paddle body 104 typically includes a plurality of electrodes 134that form an array of electrodes 133. The control module 102 typicallyincludes an electronic subassembly 110 and an optional power source 120disposed in a sealed housing 114. In FIG. 1, two lead bodies 106 areshown coupled to the control module 102.

The control module 102 typically includes one or more connectorassemblies 144 into which the proximal end of the one or more leadbodies 106 can be plugged to make an electrical connection via connectorcontacts (e.g., 316 in FIG. 3A) disposed in the connector assembly 144and terminals (e.g., 310 in FIG. 3A) on each of the one or more leadbodies 106. The connector contacts are coupled to the electronicsubassembly 110 and the terminals are coupled to the electrodes 134. InFIG. 1, two connector assemblies 144 are shown.

The one or more connector assemblies 144 may be disposed in a header150. The header 150 provides a protective covering over the one or moreconnector assemblies 144. The header 150 may be formed using anysuitable process including, for example, casting, molding (includinginjection molding), and the like. In addition, one or more leadextensions 324 (see FIG. 3C) can be disposed between the one or morelead bodies 106 and the control module 102 to extend the distancebetween the one or more lead bodies 106 and the control module 102.

It will be understood that the electrical stimulation system can includemore, fewer, or different components and can have a variety of differentconfigurations including those configurations disclosed in theelectrical stimulation system references cited herein. For example,instead of a paddle body 104, the electrodes 134 can be disposed in anarray at or near the distal end of a lead body 106′ forming apercutaneous lead 103, as illustrated in FIG. 2. The percutaneous leadmay be isodiametric along the length of the lead body 106″. The leadbody 106′ can be coupled with a control module 102′ with a singleconnector assembly 144.

The electrical stimulation system or components of the electricalstimulation system, including one or more of the lead bodies 106, thecontrol module 102, and, in the case of a paddle lead, the paddle body104, are typically implanted into the body of a patient. The electricalstimulation system can be used for a variety of applications including,but not limited to, spinal cord stimulation, brain stimulation, neuralstimulation, muscle activation via stimulation of nerves innervatingmuscle, and the like.

The electrodes 134 can be formed using any conductive, biocompatiblematerial. Examples of suitable materials include metals, alloys,conductive polymers, conductive carbon, and the like, as well ascombinations thereof. In at least some embodiments, one or more of theelectrodes 134 are formed from one or more of: platinum, platinumiridium, palladium, titanium, or rhenium.

The number of electrodes 134 in the array of electrodes 133 may vary.For example, there can be two, three, four, five, six, seven, eight,nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, or moreelectrodes 134. As will be recognized, other numbers of electrodes 134may also be used. In FIG. 1, sixteen electrodes 134 are shown. Theelectrodes 134 can be formed in any suitable shape including, forexample, round, oval, triangular, rectangular, pentagonal, hexagonal,heptagonal, octagonal, or the like.

The electrodes of the paddle body 104 or one or more lead bodies 106 aretypically disposed in, or separated by, a non-conductive, biocompatiblematerial including, for example, silicone, polyurethane, and the like orcombinations thereof. The paddle body 104 and one or more lead bodies106 may be formed in the desired shape by any process including, forexample, molding (including injection molding), casting, and the like.Electrodes and connecting wires can be disposed onto or within a paddlebody either prior to or subsequent to a molding or casting process. Thenon-conductive material typically extends from the distal end of thelead 103 to the proximal end of each of the one or more lead bodies 106.The non-conductive, biocompatible material of the paddle body 104 andthe one or more lead bodies 106 may be the same or different. The paddlebody 104 and the one or more lead bodies 106 may be a unitary structureor can be formed as two separate structures that are permanently ordetachably coupled together.

Terminals (e.g., 310 in FIG. 3A) are typically disposed at the proximalend of the one or more lead bodies 106 for connection to correspondingconductive contacts (e.g., 316 in FIG. 3A) in connector assemblies(e.g., 144 in FIG. 1) disposed on, for example, the control module 102(or to other devices, such as conductive contacts on a lead extension,an operating room cable, a splitter, an adaptor, or the like).

Conductive wires (not shown) extend from the terminals (e.g., 310 inFIG. 3A) to the electrodes 134. Typically, one or more electrodes 134are electrically coupled to a terminal (e.g., 310 in FIG. 3A). In someembodiments, each terminal (e.g., 310 in FIG. 3A) is only coupled to oneelectrode 134.

The conductive wires may be embedded in the non-conductive material ofthe lead or can be disposed in one or more lumens (not shown) extendingalong the lead. In some embodiments, there is an individual lumen foreach conductive wire. In other embodiments, two or more conductive wiresmay extend through a lumen. There may also be one or more lumens (notshown) that open at, or near, the proximal end of the lead, for example,for inserting a stylet rod to facilitate placement of the lead within abody of a patient. Additionally, there may also be one or more lumens(not shown) that open at, or near, the distal end of the lead, forexample, for infusion of drugs or medication into the site ofimplantation of the paddle body 104. The one or more lumens may,optionally, be flushed continually, or on a regular basis, with saline,epidural fluid, or the like. The one or more lumens can be permanentlyor removably sealable at the distal end.

As discussed above, the one or more lead bodies 106 may be coupled tothe one or more connector assemblies 144 disposed on the control module102. The control module 102 can include any suitable number of connectorassemblies 144 including, for example, two three, four, five, six,seven, eight, or more connector assemblies 144. It will be understoodthat other numbers of connector assemblies 144 may be used instead. InFIG. 1, each of the two lead bodies 106 includes eight terminals thatare shown coupled with eight conductive contacts disposed in a differentone of two different connector assemblies 144.

FIG. 3A is a schematic side view of one embodiment of a plurality ofconnector assemblies 144 disposed on the control module 102. In at leastsome embodiments, the control module 102 includes two connectorassemblies 144. In at least some embodiments, the control module 102includes four connector assemblies 144. In FIG. 3A, proximal ends 306 ofthe plurality of lead bodies 106 are shown configured and arranged forinsertion to the control module 102. FIG. 3B is a schematic side view ofone embodiment of a single connector assembly 144 disposed on thecontrol module 102′. In FIG. 3B, the proximal end 306 of the single leadbody 106′ is shown configured and arranged for insertion to the controlmodule 102′.

In FIGS. 3A and 3B, the one or more connector assemblies 144 aredisposed in the header 150. In at least some embodiments, the header 150defines one or more ports 304 into which the proximal end(s) 306 of theone or more lead bodies 106/106′ with terminals 310 can be inserted, asshown by directional arrows 312, in order to gain access to theconnector contacts disposed in the one or more connector assemblies 144.

The one or more connector assemblies 144 each include a connectorhousing 314 and a plurality of connector contacts 316 disposed therein.Typically, the connector housing 314 defines a port (not shown) thatprovides access to the plurality of connector contacts 316. In at leastsome embodiments, one or more of the connector assemblies 144 furtherincludes a retaining element 318 configured and arranged to fasten thecorresponding lead body 106/106′ to the connector assembly 144 when thelead body 106/106′ is inserted into the connector assembly 144 toprevent undesired detachment of the lead body 106/106′ from theconnector assembly 144. For example, the retaining element 318 mayinclude an aperture 320 through which a fastener (e.g., a set screw,pin, or the like) may be inserted and secured against an inserted leadbody 106/106′.

When the one or more lead bodies 106/106′ are inserted into the one ormore ports 304, the connector contacts 316 can be aligned with theterminals 310 disposed on the one or more lead bodies 106/106′ toelectrically couple the control module 102 to the electrodes (134 ofFIG. 1) disposed at a distal end of the one or more lead bodies 106.Examples of connector assemblies in control modules are found in, forexample, U.S. Pat. Nos. 7,244,150 and 8,224,450, which are incorporatedby reference.

In at least some embodiments, the electrical stimulation system includesone or more lead extensions. The one or more lead bodies 106/106′ can becoupled to one or more lead extensions which, in turn, are coupled tothe control module 102/102′. In FIG. 3C, a lead extension connectorassembly 322 is disposed on a lead extension 324. The lead extensionconnector assembly 322 is shown disposed at a distal end 326 of the leadextension 324. The lead extension connector assembly 322 includes acontact housing 328. The contact housing 328 defines at least one port330 into which a proximal end 306 of the lead body 106′ with terminals310 can be inserted, as shown by directional arrow 338. The leadextension connector assembly 322 also includes a plurality of connectorcontacts 340. When the lead body 106′ is inserted into the port 330, theconnector contacts 340 disposed in the contact housing 328 can bealigned with the terminals 310 on the lead body 106 to electricallycouple the lead extension 324 to the electrodes (134 of FIG. 1) disposedat a distal end (not shown) of the lead body 106′.

The proximal end of a lead extension can be similarly configured andarranged as a proximal end of a lead body. The lead extension 324 mayinclude a plurality of conductive wires (not shown) that electricallycouple the connector contacts 340 to terminal on a proximal end 348 ofthe lead extension 324. The conductive wires disposed in the leadextension 324 can be electrically coupled to a plurality of terminals(not shown) disposed on the proximal end 348 of the lead extension 324.In at least some embodiments, the proximal end 348 of the lead extension324 is configured and arranged for insertion into a lead extensionconnector assembly disposed in another lead extension. In otherembodiments (as shown in FIG. 3C), the proximal end 348 of the leadextension 324 is configured and arranged for insertion into theconnector assembly 144 disposed on the control module 102′.

It will be understood that the control modules 102/102′ can receiveeither lead bodies 106/106′ or lead extensions 324. It will also beunderstood that the electrical stimulation system 100 can include aplurality of lead extensions 224. For example, each of the lead bodies106 shown in FIGS. 1 and 3A can, alternatively, be coupled to adifferent lead extension 224 which, in turn, are each coupled todifferent ports of a two-port control module, such as the control module102 of FIGS. 1 and 3A.

Turning to FIG. 4A, some target stimulation locations are located inproximity to one or more bony structures. When stimulating a region inproximity to one or more bony structures, it may be desirable to anchorthe lead to the bony structure in order to prevent migration of thedistal end of the lead which, in at least some cases, may disruptefficacious stimulation.

One potential target stimulation location in proximity to a bonystructure is the dorsal root ganglia. FIG. 4A schematically illustratesa transverse cross-sectional view of a spinal cord 402 surrounded bydura 404. The spinal cord 402 includes a plurality of levels from whichspinal nerves 412 a and 412 b extend. In at least some spinal cordlevels, the spinal nerves 412 a and 412 b extend bilaterally from thespinal cord 402. In FIG. 4A, the spinal nerves 412 a and 412 b attach tothe spinal cord 402 via corresponding dorsal roots 414 a and 414 b andcorresponding ventral (or anterior) roots 416 a and 416 b. Typically,the dorsal roots 414 a and 414 b relay sensory information into thespinal cord 402 and the ventral roots 416 a and 416 b relay motorinformation outward from the spinal cord 402. Dorsal root ganglia(“DRG”) 420 a and 420 b are nodules of cell bodies that are disposedalong the dorsal roots 416 a and 416 b in proximity to the spinal cord402.

FIG. 4B schematically illustrates a perspective view of a portion of thespinal cord 402 disposed along a portion of a vertebral column 430. Thevertebral column 430 includes a plurality of stacked vertebrae, such asvertebrae 432 a and 432 b, and a plurality of DRGs 420 a and 420 bextending outwardly bilaterally from the spinal cord 402.

FIG. 4C schematically illustrates a top view of a portion of the spinalcord 402 and dura 404 disposed in a vertebral foramen 440 defined in thevertebra 432 b. The vertebrae, such as the vertebrae 432 a and 432 b,are stacked together and the vertebral foramina 440 of the vertebraecollectively form a spinal canal through which the spinal cord 402extends. The space within the spinal canal between the dura 404 and thewalls of the vertebral foramen 440 defines the epidural space 442.Intervertebral foramina 446 a and 446 b, defined bilaterally along sidesof the vertebra 432 b, form openings through the vertebra 432 b betweenthe epidural space 442 and the environment external to the vertebra 432b.

FIG. 4D schematically illustrates a side view of two vertebrae 432 a and432 b coupled to one another by a disc 444. In FIG. 4D, theintervertebral foramen 446 b is shown defined between the vertebrae 432a and 432 b. The intervertebral foramen 446 b provides an opening forone or more of the dorsal root 414 b, ventral root 416 b, and DRG 420 bto extend outwardly from the spinal cord 402.

Turning to FIG. 5A, as herein described one or more leads can beanchored to one or more bony structures in proximity to a targetstimulation location. In at least some embodiments, the one or moreleads are anchored to one or more vertebrae in proximity to the targetstimulation location. It will be understood that the systems and methodsdiscussed herein may be applicable to other bony structures of thepatient including, for example, the skull, pelvis, scapulae, humerus,femur, or the like. In at least some embodiments, the target stimulationlocation is the DRG. It will be understood that the systems and methodsdiscussed herein may be applicable to other target stimulation locationswithin the patient including, for example, other portions of the sensorynerves (e.g., the dorsal root or the ventral root), or other patienttissue in proximity to one or more other bony structures, besides thevertebrae.

Individuals with spinal orthopedic ailments may receive one or moreorthopedic implants (e.g., rods, plates, straps, screws, or the like orcombinations thereof) to provide therapy to the patient. In some cases,the orthopedic implants may span between two or more bony structures.For example, the orthopedic implant may span between two or more of thepatient's vertebrae at a particular spinal cord level. In at least someembodiments, the one or more leads can be coupled to the one or moreorthopedic implants such that the electrodes of the one or more lead aredisposed on the orthopedic implant. In which case, the electrodes can bedisposed along the orthopedic implant such that the electrodes arepositioned in proximity to a target stimulation location in proximity tothe one or more bony structures at the particular spinal cord level,such as the particular DRG disposed in proximity to the spinal cordlevel across which the orthopedic implant spans.

Orthopedic implants can be implanted into the patient in any suitablemanner including, for example, using a series of hollow introducers.Further description of a series of hollow introducers can be found inU.S. Provisional Patent Application Ser. No. 61/651,815, incorporatedherein by reference.

FIG. 5A is a schematic bottom view of one embodiment of a distal end ofa body of a lead 502 coupled to an orthopedic implant 504. FIG. 5B is aschematic side view of one embodiment of the distal end of the body ofthe lead 502 coupled to the orthopedic implant 504. The lead 502includes a plurality of terminals (see e.g., terminals 310 of FIGS.3A-3C) disposed along a proximal end of the body of the lead 502. Theterminals are configured and arranged for electrically coupling with thecontrol module (see e.g., 102 in FIG. 1) either directly, or via one ormore intermediate components, such as a lead extension (see e.g., 324 ofFIG. 3C).

The orthopedic implant 504 includes an elongated body 506 with one ormore mounting regions 508 and one or more stimulation regions 510. InFIGS. 5A-5B, the body 506 is shown with two mounting regions 508disposed on opposing ends of the body 506. In at least some embodiments,the one or more stimulation regions 510 are disposed between two or moremounting regions 508.

In at least some embodiments, the one or more mounting regions 508 arecoupled to the one or more stimulation regions 510 via one or moretransition regions 512. In at least some embodiments, the one or moremounting regions 508 are planar. In at least some embodiments, the oneor more stimulation regions 510 are planar. In FIGS. 5A-5B, the mountingregions 508 and the stimulation region 510 are shown extending parallelto one another, while the transition regions 512 are shown as bent, orangled, regions that are not parallel to either the mounting regions 508or the stimulation region 510, and that function to position thestimulation region 510 away from the mounting regions 508 and closer toa target stimulation region.

One or more mounting apertures 518 are disposed on each of the mountingregions 508. The one or more mounting apertures 518 are each configuredand arranged for receiving a fastener (e.g., a bone screw, bolt,staples, sutures, or the like) 520. In at least some embodiments, one ormore adhesives may be used in addition to, or in lieu of, extending thefastener 520 through the one or more mounting aperture 518. Any suitablenumber of mounting apertures 518 can be defined in the one or moremounting regions 508 including, for example, one, two, three, four,five, six, seven, eight, nine, ten, eleven, twelve, or more mountingapertures 518. In FIGS. 5A-5B (and in other figures), a single mountingaperture 518 is defined in each of the mounting regions 508.

In at least some embodiments, the mounting apertures 518 are positionedalong the body such that the mounting apertures 518 align simultaneouslywith potential mounting surfaces of two different bony structures, suchas two adjacent vertebrae 432. In at least some embodiments, the spacingbetween a first mounting aperture of the plurality of mounting apertures518 and a second mounting aperture of the plurality of mountingapertures 518 is equal to the spacing between two adjacent vertebrae 432of the patient.

One or more electrodes, such as electrode 526, are disposed on theorthopedic implant 504. In at least some embodiments, the one or moreelectrodes 526 are disposed on the stimulation region of the orthopedicimplant. In at least some embodiments, the one or more electrodes 526are disposed along a bottom surface of the one or more stimulationregions such that the stimulation region is disposed between theelectrodes 526 and the mounting regions 508, thereby directingstimulation propagating from the electrodes 526 towards the targetstimulation location.

Any suitable number of electrodes 526 can be disposed on the orthopedicimplant including, for example, one, two, three, four, five, six, seven,eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen,twenty, twenty-four, twenty-eight, thirty-two, forty, forty-eight, ormore. In at least some embodiments, the one or more electrodes 526extend outwardly from an outer surface of the orthopedic implant. Inalternate embodiments, the one or more electrodes 526 are flush with, orinset from, the outer surface of the orthopedic implant. The one or moreelectrodes 526 can be formed in any suitable shape including, forexample, round, oval, triangular, rectangular, or the like. It will beunderstood that the one or more electrodes 526 can be formed into othershapes, as well, either regular or irregular.

The one or more electrodes 526 are electrically coupled to the lead 502via one or more conductors 528 a disposed on or in the orthopedicimplant. In at least some embodiments, the one or more conductors 528 aare electrically coupled to one or more conductors 528 b that aredisposed along the body of the lead 502 and that electrically couple tothe terminals disposed along the proximal end of the lead 502. In atleast some alternate embodiments, the control module may couple directlyto the orthopedic implant 504. In which case, the one or more conductors528 a electrically couple with conductors within the control module.

The one or more conductors 528 a can be formed in any suitable mannerincluding, for example, multi-filar conductive wires, single-filarconductive wires, conductive tracings, or the like. In at least someembodiments, the conductors 528 a are formed along the body of theorthopedic implant as one or more conductive portions of the body.

In at least some embodiments, the body 506 of the orthopedic implant 504is more rigid than the body of the lead 502. In at least someembodiments, the body 506 of the orthopedic implant 504 is formed from amaterial that maintains its shape once the orthopedic implant 504 isimplanted in the patient. The orthopedic implant 504 can be formed fromany rigid material suitable for implantation including, for example,titanium, stainless steel, one or more alloys, composite material, orthe like.

In at least some embodiments, the body 506 of the orthopedic implant 504is formed from a non-conductive material. In at least some embodiments,the body 506 of the orthopedic implant 504 is formed from a conductivematerial and includes one or more non-conductive layers of materialdisposed over one or more portions of an outer surface of the conductivematerial of the orthopedic implant 504.

The body 506 of the orthopedic implant 504 has a length 532 and a width534. In at least some embodiments, the width 534 of the body 506 isgreater than a diameter of the body of the lead 502. In at least someembodiments, the length 532 of the body 506 is smaller than alongitudinal length of the body of the lead 502. In at least someembodiments, the length 532 of the body 506 is substantially smallerthan a longitudinal length of the body of the lead 502.

As shown in FIG. 5A, in at least some embodiments the stimulation region510 is longitudinally aligned with the opposing mounting regions 508along the length 532 of the body 506. As shown in FIG. 5A, in at leastsome embodiments the width 534 of the body 506 is constant along theentire length 532 of the body 506.

In FIGS. 5A-5B, the lead 502 is shown coupled to the body 506 of theorthopedic implant 504 along one of the mounting regions 508. Inalternate embodiments, the lead 502 couples to the body 506 of theorthopedic implant 504 along the one or more stimulation regions 510, oralong the one or more transition regions 512, or both.

In FIG. 5B, the stimulation region 510 is shown as being recessed fromthe mounting regions 508. When a particular DRG is the targetstimulation location, it may be advantageous to form the stimulationregion 510 as a recessed region of the body 606 to position theelectrodes 526 closer to the DRG when the orthopedic implant 504 ismounted to two adjacent vertebrae 432 flanking the DRG.

FIG. 5C is a schematic top view of one embodiment of the orthopedicimplant 504 anchored to two adjacent vertebrae 432 a and 432 b disposedin proximity to a target stimulation region. FIG. 5D is a schematic sideview of one embodiment of the orthopedic implant 504 anchored to twoadjacent vertebrae 432 a and 432 b flanking the targeted DRG 420 a. Theorthopedic implant 504 is mounted to the vertebrae 432 a such that oneof two fasteners 520 is passed through the mounting aperture of one ofthe two mounting regions 508 and into the vertebrae 432 a, while theother of the two fasteners 520 is passed through the mounting apertureof the other of the two mounting regions 508 and into the vertebrae 432b.

In FIG. 5D, the stimulation region 510 of the body 506 of the orthopedicimplant 504 is shown recessed from the mounting regions 508 such thatthe electrodes 526 are positioned in proximity to the DRG 420 a. It willbe understood that the orthopedic implant of FIGS. 5A-5D (as well asother orthopedic implants discussed herein) can be mounted to more thantwo vertebrae. It will also be understood that the orthopedic implant ofFIGS. 5A-5D (as well as other orthopedic implants discussed herein) canbe coupled to vertebrae that are not adjacent to one another.

In at least some embodiments, the one or more stimulation regions arelongitudinally offset from the opposing mounting regions. FIG. 6A is aschematic bottom view of a second embodiment of the distal end of thebody of the lead 502 coupled to an orthopedic implant 604. FIG. 6B is aschematic side view of one embodiment of the distal end of the body ofthe lead 502 coupled to the orthopedic implant 604. The orthopedicimplant 604 includes an elongated body 606 with the mounting regions 508disposed on opposing ends of the body 606 and a stimulation region 610disposed therebetween. In at least some embodiments, the stimulationregion 610 is disposed between the mounting regions 508 such that thestimulation region 610 is longitudinally offset from the opposingmounting regions 508.

In FIGS. 6A-6B, the mounting regions 508 are shown coupled to thestimulation region 610 via one or more transition regions 612. In atleast some embodiments, the mounting regions 508 are planar. In at leastsome embodiments, the stimulation region 610 is planar. In FIGS. 6A-6B,the mounting regions 508 and the stimulation region 610 are shown asextending parallel to one another, while the transition region 612 isshown as a bent (or angled) region that is not parallel to either themounting regions 508 or the stimulation region 610, and that functionsto position the stimulation region 610 away from the mounting regions508 and closer to a target stimulation region.

One or more electrodes, such as electrode 526, are disposed on theorthopedic implant 604. In at least some embodiments, the one or moreelectrodes 526 are disposed on the stimulation region of the orthopedicimplant. In at least some embodiments, the one or more electrodes 526are disposed along a bottom surface of the one or more stimulationregions such that the stimulation region is disposed between theelectrodes 526 and the mounting regions 508, thereby directingstimulation propagating from the electrodes 526 towards the targetstimulation region.

The one or more electrodes 526 are electrically coupled to the lead 502via one or more conductors 528 a disposed on or in the orthopedicimplant. In at least some embodiments, the one or more conductors 528 aare electrically coupled to one or more conductors 528 b that aredisposed along the body of the lead 502 and that electrically couple tothe terminals disposed along the proximal end of the lead 502. In atleast some alternate embodiments, the control module may couple directlyto the orthopedic implant 504. In which case, the one or more conductors528 a electrically couple with conductors within the control module.

The one or more conductors 528 a can be formed in any suitable mannerincluding, for example, multi-filar conductive wires, single-filarconductive wires, conductive tracings, or the like. In at least someembodiments, the conductors 528 a are formed along the body of theorthopedic implant as one or more conductive portions of the body.

In at least some embodiments, the body 606 of the orthopedic implant 604is more rigid than the body of the lead 502. In at least someembodiments, the body 606 of the orthopedic implant 604 is formed from amaterial that maintains its shape once the orthopedic implant 604 isimplanted in the patient. The orthopedic implant 604 can be formed fromany rigid material suitable for implantation including, for example,titanium, stainless steel, one or more alloys, composite material, orthe like. In at least some embodiments, the body 606 of the orthopedicimplant 604 is formed from a non-conductive material. In at least someembodiments, the body 606 of the orthopedic implant 604 is formed from aconductive material and includes one or more non-conductive layers ofmaterial disposed over one or more portions of an outer surface of theconductive material of the orthopedic implant 604.

The body 606 of the orthopedic implant 604 has a length 632 and a width634. In at least some embodiments, the width 634 of the body 606 isgreater than a diameter of the body of the lead 502. In at least someembodiments, the length 632 of the body 606 is smaller than alongitudinal length of the body of the lead 502. As shown in FIG. 6A, inat least some embodiments the stimulation region 610 is longitudinallyoffset from the mounting regions 508. In at least some embodiments, thestimulation region 610 or the one or more transition regions 612 extendfrom a side surface one (or both) of the mounting regions 508.

In FIG. 6B, the stimulation region 610 is shown as being recessed fromthe mounting region 508. When a particular DRG is the target stimulationlocation, it may be advantageous to form the stimulation region 610 as arecessed region of the body 606 to position the electrodes 526 closer tothe DRG when the orthopedic implant 604 is mounted to two adjacentvertebrae 432 flanking the DRG.

FIG. 6C is a schematic top view of one embodiment of the orthopedicimplant 604 anchored to two adjacent vertebrae 432 a and 432 b disposedin proximity to a target stimulation region. FIG. 6D is a schematic sideview of one embodiment of the orthopedic implant 604 anchored to twoadjacent vertebrae 432 a and 432 b flanking the targeted DRG 420 a. Theorthopedic implant 604 is mounted to the vertebrae 432 a such that oneof two fasteners 520 is passed through the mounting aperture of one ofthe two mounting regions 508 and into the vertebrae 432 a, while theother of the two fasteners 520 is passed through the mounting apertureof the other of the two mounting regions 508 and into the vertebrae 432b.

In FIG. 6D, the stimulation region 610 of the body 606 of the orthopedicimplant 604 is shown recessed from the mounting region 508 such that theelectrodes 526 are positioned in proximity to the DRG 420 a. It will beunderstood that the orthopedic implant of FIGS. 6A-6D (as well as otherorthopedic implants discussed herein) can be mounted to more than twovertebrae. It will also be understood that the orthopedic implant ofFIGS. 6A-6D (as well as other orthopedic implants discussed herein) canbe coupled to vertebrae that are not adjacent to one another.

In at least some embodiments, the one or more stimulation regions arearc-shaped. FIG. 7A is a schematic bottom view of a third embodiment ofa distal end of the body of the lead 502 coupled to an orthopedicimplant 704. FIG. 7B is a schematic side view of one embodiment of thedistal end of the body of the lead 502 coupled to the orthopedic implant704.

The orthopedic implant 704 includes an elongated body 706 with themounting regions 508 disposed on opposing ends of the body 706 and astimulation region 710 disposed therebetween. In at least someembodiments, the stimulation region 710 is disposed between the mountingregions 508 such that the stimulation region 710 is longitudinallyoffset from the opposing mounting regions 508.

In FIGS. 7A-7B, the mounting regions 508 are shown coupled to thestimulation region 710 via one or more transition regions 712. In atleast some embodiments, the mounting regions 508 are planar. In FIGS.7A-7B, the stimulation region 710 is shown as being arc-shaped, suchthat the target stimulation region can be disposed within the arc formedby the stimulation region 710. In at least some embodiments, thetransition region 712 is a bent (or angled) region that functions toposition the stimulation region 710 away from the mounting regions 508and closer to a target stimulation location.

One or more electrodes, such as electrode 526, are disposed on theorthopedic implant 704. In at least some embodiments, the one or moreelectrodes 526 are disposed on the stimulation region of the orthopedicimplant. In at least some embodiments, the one or more electrodes 526are disposed along a bottom surface of the stimulation region (e.g., onan inner surface of the arc formed by the stimulation region) such thatthe stimulation region is disposed between the electrodes 526 and themounting regions 508, thereby directing stimulation propagating from theelectrodes 526 towards the target stimulation location.

The one or more electrodes 526 are electrically coupled to the lead 502via one or more conductors 528 a disposed on or in the orthopedicimplant. In at least some embodiments, the one or more conductors 528 aare electrically coupled to one or more conductors 528 b that aredisposed along the body of the lead 502 and that electrically couple tothe terminals disposed along the proximal end of the lead 502. In atleast some alternate embodiments, the control module may couple directlyto the orthopedic implant 504. In which case, the one or more conductors528 a electrically couple with conductors within the control module.

In at least some embodiments, the body 706 of the orthopedic implant 704is more rigid than the body of the lead 502. In at least someembodiments, the body 706 of the orthopedic implant 704 is formed from amaterial that maintains its shape once the orthopedic implant 704 isimplanted in the patient. The orthopedic implant 704 can be formed fromany rigid material suitable for implantation including, for example,titanium, stainless steel, one or more alloys, composite material, orthe like. In at least some embodiments, the body 706 of the orthopedicimplant 704 is formed from a non-conductive material. In at least someembodiments, the body 706 of the orthopedic implant 704 is formed from aconductive material and includes one or more non-conductive layers ofmaterial disposed over at least one or more portions of an outer surfaceof the conductive material of the orthopedic implant 704.

The body 706 of the orthopedic implant 704 has a length 732 and a width734. In at least some embodiments, the width 734 of the body 706 isgreater than a diameter of the body of the lead 502. In at least someembodiments, the length 732 of the body 706 is smaller than alongitudinal length of the body of the lead 502. As shown in FIG. 7A, inat least some embodiments the stimulation region 710 longitudinallyoffset from the mounting regions 508. In at least some embodiments, thestimulation region 710 or the one or more transition regions 712 extendfrom a side surface one (or both) of the mounting regions 508.

In FIG. 7B, the stimulation region 710 is shown as being recessed fromthe mounting region 508. When a particular DRG is the target stimulationlocation, it may be advantageous to form the stimulation region 710 as arecessed region of the body 706 to position the electrodes 526 closer tothe DRG when the orthopedic implant 704 is mounted to two adjacentvertebrae 432 flanking the DRG.

FIG. 7C is a schematic top view of one embodiment of the orthopedicimplant 704 anchored to two adjacent vertebrae 432 a and 432 b disposedin proximity to a target stimulation region. FIG. 7D is a schematic sideview of one embodiment of the orthopedic implant 704 anchored to twoadjacent vertebrae 432 a and 432 b flanking the targeted DRG 420 a. Theorthopedic implant 704 is mounted to the vertebrae 432 a such that oneof two fasteners 520 is passed through the mounting aperture of one ofthe two mounting regions 508 and into the vertebrae 432 a, while theother of the two fasteners 520 is passed through the mounting apertureof the other of the two mounting regions 508 and into the vertebrae 432b.

In FIG. 7D, the stimulation region 710 of the body 706 of the orthopedicimplant 704 is shown recessed from the mounting region 508 such that theelectrodes 526 are positioned in proximity to the DRG 420 a. It will beunderstood that the orthopedic implant of FIGS. 7A-7D (as well as otherorthopedic implants discussed herein) can be mounted to more than twovertebrae. It will also be understood that the orthopedic implant ofFIGS. 7A-7D (as well as other orthopedic implants discussed herein) canbe coupled to vertebrae that are not adjacent to one another.

In at least some embodiments, the orthopedic implant is configured andarranged to mount to a single bony structure. FIG. 8A is a schematicside view of a fourth embodiment of a distal end of a body of the lead502 coupled to an orthopedic implant 804. In at least some embodiments,the orthopedic implant 804 is formed as an elongated enhanced fastener(e.g., a bone screw, bolt, staple, or the like) 820. The enhancedfastener 820 includes a head 840 and a shaft 842 coupled to the head 840at one end of the shaft 842. The shaft 842 has a length 832 and includesa tip 844 opposite to the head 840. The tip 844 is configured andarranged to penetrate a bony structure. In at least some embodiments,the enhanced fastener 804 includes one or more threads 846 extendingalong the shaft 842. The one or more threads 846 may facilitatepenetration of the bony structure, or anchoring of the enhanced fastener804 to the bony structure, or both.

One or more electrodes 526 are disposed along the shaft 842 in proximityto the tip 844 of the enhanced fastener 820. Alternately, the tip 844itself may be formed as an electrode. The one or more electrodes 526 areelectrically coupled to the lead 502 via one or more conductors 528 adisposed on or in the orthopedic implant. In at least some embodiments,the one or more conductors 528 a are electrically coupled to one or moreconductors 528 b that are disposed along the body of the lead 502 andthat electrically couple to the terminals disposed along the proximalend of the lead 502. In at least some alternate embodiments, the controlmodule may couple directly to the orthopedic implant 504. In which case,the one or more conductors 528 a electrically couple with conductorswithin the control module.

In at least some embodiments, the length 832 of the shaft 842 is greaterthan a thickness of the bony structure to which the enhanced fastener804 is configured to anchor. In which case, the enhanced fastener 804may be configured and arranged for extending completely through the bonystructure when the enhanced fastener 804 is anchored to the bonystructure such that the tip 844 of the enhanced fastener 804 extendsoutwardly from a surface of the bony structure.

FIG. 8B is a schematic side view of one embodiment of the orthopedicimplant 804 anchored to the vertebra 432 a such that the shaft 842extends completely through the vertebrae 432 a with the tip 844extending outwardly from a surface of the vertebra 432 a that isopposite from the head 840. In FIG. 8B, the one or more electrodes 526are disposed along the tip 844 and are positioned in proximity to theDRG 420 a. In at least some embodiments, the one or more electrodes 526are configured and arranged for coupling to the tip 844 after theenhanced fastener 804 is anchored to the bony structure and extendedtherethrough. In which case, the one or more electrodes 804 can beeither removably or permanently coupled to the tip 844 using anysuitable technique (e.g., adhesive, screw, bolt, snap, sutures,interference fit, or the like or combinations thereof).

As shown in FIG. 8B, in at least some embodiments when the enhancedfastener 804 is anchored to the bony structure the head 840 of theenhanced fastener 804 extends from a first surface of the bony structurewhile the tip 844 extends outwardly from a second surface of the bonystructure, opposite to the first surface. Alternately, in at least someembodiments when the enhanced fastener 804 is fastened to the bonystructure the head 840 of the enhanced fastener 804 is flush with, orinset from, the first surface of the bony structure while the tip 844extends outwardly from the second surface of the bony structure.

In at least some embodiments, the one or more electrodes 526 arebendable. FIG. 8C is a schematic side view of another embodiment of theorthopedic implant 804 anchored to one of the vertebrae 432 a. FIG. 8Dis a schematic top view of the embodiment of the orthopedic implant 804shown in FIG. 8C anchored to one of the vertebrae 432 a. As shown inFIGS. 8C and 8D, the one or more electrodes 526 are configured andarranged to bend. In which case, the one or more electrodes 526 can bebent so that the one or more electrodes 526 are disposed in proximity tothe target stimulation region (e.g., the DRG, or the like) 420 a.

It may be advantageous for the one or more electrodes to be bendable sothat the one or more electrodes 526 can be positioned more closely tothe target stimulation region after the enhanced fastener 804 isanchored to the bony structure, thereby reducing the potential forundesirably stimulating non-targeted tissue in proximity to the targetstimulation location.

In at least some embodiments, instead of disposing one or moreelectrodes along a body of the orthopedic implant (as shown anddiscussed with reference to FIGS. 5A-8D), the orthopedic implant isconfigured and arranged to retain one or more leads. FIG. 9A is aschematic top view of a fifth embodiment of an orthopedic implant 904that includes an anchoring unit suitable for anchoring one or more leadsto one or more of the vertebrae 432. FIG. 9B is a schematic side view ofone embodiment of the orthopedic implant 904. In at least someembodiments, the orthopedic implant 904 is configured and arranged toanchor one or more leads to the orthopedic implant 904 such thatelectrodes disposed along the one or more leads can be positioned inproximity to a target stimulation location (e.g., a DRG, or the like).

The orthopedic implant 904 includes an elongated body 906 having one ormore mounting regions 508 with mounting apertures 518 for mounting theorthopedic implant 904 to one or more bony structures. The orthopedicimplant 904 also includes one or more lead anchoring regions 970 foranchoring the one or more leads to the orthopedic implant 904.

In at least some embodiments, the one or more lead anchoring regions 970are disposed between two or more mounting regions 508. In at least someembodiments, the one or more lead anchoring regions 970 are disposedbetween the mounting regions 508 such that the one or more leadanchoring regions 970 are aligned along a longitudinal axis with the twoor more mounting regions 508 disposed on opposing ends of the body 906.In at least some other embodiments, the one or more lead anchoringregions 970 are longitudinally offset from the mounting regions 508. Inat least some embodiments, the body 906 additionally includes one ormore transition regions coupling the one or more mounting regions 508 tothe one or more lead anchoring regions 508.

In at least some embodiments, the one or more lead anchoring regions 970are recessed from the one or more mounting region 508. When a particularDRG is the target stimulation location, it may be advantageous to formthe one or more anchoring regions 970 as a recessed region of the body906 in order to position the electrodes 526 closer to the DRG when theorthopedic implant 904 is mounted to two adjacent vertebrae 432 flankingthe DRG.

In at least some embodiments, the body 906 of the orthopedic implant 904is formed from a material that maintains its shape once the orthopedicimplant 904 is implanted in the patient. The orthopedic implant 904 canbe formed from any rigid material suitable for implantation including,for example, titanium, stainless steel, one or more alloys, compositematerial, or the like. In at least some embodiments, the body 906 of theorthopedic implant 904 is formed from a non-conductive material. In atleast some embodiments, the body 906 of the orthopedic implant 904 isformed from a conductive material and includes one or morenon-conductive layers of material disposed over at least one or moreportions of an outer surface of the conductive material of theorthopedic implant 904.

In at least some embodiments, the one or more lead anchoring regions 970are configured and arranged to anchor one or more leads to theorthopedic implant 904 such that electrodes disposed on the one or moreleads can be positioned in proximity to a target stimulation location(e.g., a DRG, or the like).

In at least some embodiments, the one or more lead anchoring regions 970each includes one or more lead lumens 974, where each of the one or morelead lumens 974 is configured and arranged to receive a portion of alead. In at least some embodiments, the one or more lead anchoringregions 970 each includes one or more fastener lumens 976 that intersectwith the one or more lead lumens 974 and that are configured andarranged to receive a fastener (e.g., a screw, pin, clamp, latch, lug,nail, bolt, dowel, rod, rivet, or the like or combinations thereof) forfastening against a portion of a lead when the lead is inserted into thelead lumen 974. Examples of anchoring regions configured and arrangedfor receiving portions of leads are found in, for example, U.S. PatentApplication Publication No. 2010/0274336; 2011/0178573; and2012/0185027, all of which are incorporated by reference.

In at least some embodiments, the orthopedic implant 904 is configuredand arranged to anchor one or more percutaneous leads (see e.g., FIG. 2)to the one or more bony structures. FIG. 9C is a schematic top view ofone embodiment of distal ends of two percutaneous leads 980 a and 980 bextending through the lead lumens 974. Each of the percutaneous leads980 a and 980 b includes a plurality of terminals (see e.g., terminals310 of FIGS. 3A-3C) disposed at proximal ends of the percutaneous leads980 a and 980 b. Fasteners 978 (e.g., screws, pins, clamps, latches,lugs, nails, bolts, dowels, rods, rivets, or the like or combinationsthereof) are extended along the fastener lumens 976 and used to fastenthe percutaneous leads 980 a and 980 b to the orthopedic implant 904.

A plurality of electrodes, such as electrodes 982 a and 982 b, aredisposed along the distal ends of the percutaneous leads 980 a and 980b, respectively. As shown in FIG. 9C, in at least some embodiments theone or more lead lumens 974 are configured and arranged to receive aportion of a distal end of the percutaneous leads 980 a and 980 b. In atleast some embodiments, the one or more lead lumens 974 are configuredand arranged to receive a portion of the distal end of the percutaneousleads 980 a and 980 b proximal to the plurality of electrodes 982 a and982 b.

The electrodes 982 a and 982 b can be any suitable shape, such asring-shaped, cuff-shaped, arc-shaped or segmented. Examples of leadswith segmented electrodes include U.S. Pat. Nos. 8,295,944; and8,391,985; U.S. Patent Application Publications Nos. 2010/0268298;2011/0005069; 2011/0078900; 2011/0130817; 2011/0130818; 2011/0238129;2011/0313500; 2012/0016378; 2012/0046710; 2012/0165911; 2012/0197375;2012/0203316; 2012/0203320; 2012/0203321, all of which are incorporatedherein by reference. It may be advantageous for the electrodes 982 a and982 b to be shaped such that stimulation energy propagated from theelectrodes 982 a and 982 b is directed primarily towards the targetstimulation location. For example, it may be advantageous to form theelectrodes 982 a and 982 b such that they do not extend completelyaround the circumference of the body of the percutaneous leads 980 a and980 b.

In at least some embodiments that use directional electrodes, theproximal ends of the bodies of the percutaneous leads 980 a and 980 binclude markers identifying the directionality of the electrodes 982 aand 982 b. The markers may be used to facilitate implantation byenabling a practitioner to be able to recognize the orientation of theelectrodes in the implanted leads by visually inspecting the markersdisposed at the proximal ends of the leads.

FIG. 9D is a schematic top view of one embodiment of the orthopedicimplant 904 anchored to two of the vertebrae 432 a and 432 b byfasteners 520. Two percutaneous leads 980 a and 980 b are fastened tothe orthopedic implant 904 such that the electrodes 982 a and 982 b ofthe percutaneous leads 980 a and 980 b, respectively, are disposed inproximity to the DRG 420 a. It will be understood that the orthopedicimplant can be anchored to the one or more bony structures either beforeor after the one or more leads are fastened to the orthopedic implant.

In at least some embodiments, the orthopedic implant 904 is configuredand arranged to anchor one or more paddle leads (see e.g., FIG. 1) tothe one or more bony structures. FIG. 9E is a schematic top view of oneembodiment of a paddle lead 990 fastened to the orthopedic implant 904.The paddle lead 990 includes a paddle body 992 and a plurality of leadbodies 994 coupled to the paddle body 992. A plurality of electrodes,including electrode 996, are disposed on the paddle body 992.

Each of the lead bodies 994 includes a plurality of terminals (see e.g.,terminals 310 of FIGS. 3A-3C) disposed at proximal ends of the leadbodies 994. The lead bodies 994 of the paddle lead 990 are shown in FIG.9E extending through the lead lumens 974 and fastened to the orthopedicimplant 904 by fasteners 978 extended along the fastener lumens 976.

In FIG. 9E, the electrodes 996 are shown disposed along a bottom surfaceof the paddle body 992. It may be advantageous for the electrodes 996 tobe oriented such that stimulation energy propagated from the electrodes996 is directed towards the target stimulation location. For example,when the orthopedic implant 904 is anchored to a bony structure disposedabove the target stimulation location, it may be advantageous to orientthe lead(s) such that the electrodes face downward, towards the targetstimulation location, such as is shown in FIG. 9D.

In FIGS. 9A-9E the orthopedic implant 904 is shown with an elongatedbody 906 configured and arranged to mount to, and extend between, twobony structures. In at least some embodiments, the orthopedic implant904 may be configured and arranged to mount to a single bony structure.For example, in at least some embodiments the one or more lead anchoringregions 970 are coupled to the enhanced fastener 804.

FIG. 10 is a schematic overview of one embodiment of components of anelectrical stimulation system 1000 including an electronic subassembly1010 disposed within a control module. It will be understood that theelectrical stimulation system can include more, fewer, or differentcomponents and can have a variety of different configurations includingthose configurations disclosed in the stimulator references citedherein.

Some of the components (for example, power source 1012, antenna 1018,receiver 1002, and processor 1004) of the electrical stimulation systemcan be positioned on one or more circuit boards or similar carrierswithin a sealed housing of an implantable pulse generator, if desired.Any power source 1012 can be used including, for example, a battery suchas a primary battery or a rechargeable battery. Examples of other powersources include super capacitors, nuclear or atomic batteries,mechanical resonators, infrared collectors, thermally-powered energysources, flexural powered energy sources, bioenergy power sources, fuelcells, bioelectric cells, osmotic pressure pumps, and the like includingthe power sources described in U.S. Pat. No. 7,437,193, incorporatedherein by reference.

As another alternative, power can be supplied by an external powersource through inductive coupling via the optional antenna 1018 or asecondary antenna. The external power source can be in a device that ismounted on the skin of the user or in a unit that is provided near theuser on a permanent or periodic basis.

If the power source 1012 is a rechargeable battery, the battery may berecharged using the optional antenna 1018, if desired. Power can beprovided to the battery for recharging by inductively coupling thebattery through the antenna to a recharging unit 1016 external to theuser. Examples of such arrangements can be found in the referencesidentified above.

In one embodiment, electrical current is emitted by the electrodes 134on the paddle or lead body to stimulate nerve fibers, muscle fibers, orother body tissues near the electrical stimulation system. A processor1004 is generally included to control the timing and electricalcharacteristics of the electrical stimulation system. For example, theprocessor 1004 can, if desired, control one or more of the timing,frequency, strength, duration, and waveform of the pulses. In addition,the processor 1004 can select which electrodes can be used to providestimulation, if desired. In some embodiments, the processor 1004 mayselect which electrode(s) are cathodes and which electrode(s) areanodes. In some embodiments, the processor 1004 may be used to identifywhich electrodes provide the most useful stimulation of the desiredtissue.

Any processor can be used and can be as simple as an electronic devicethat, for example, produces pulses at a regular interval or theprocessor can be capable of receiving and interpreting instructions froman external programming unit 1008 that, for example, allows modificationof pulse characteristics. In the illustrated embodiment, the processor1004 is coupled to a receiver 1002 which, in turn, is coupled to theoptional antenna 1018. This allows the processor 1004 to receiveinstructions from an external source to, for example, direct the pulsecharacteristics and the selection of electrodes, if desired.

In one embodiment, the antenna 1018 is capable of receiving signals(e.g., RF signals) from an external telemetry unit 1006 which isprogrammed by a programming unit 1008. The programming unit 1008 can beexternal to, or part of, the telemetry unit 1006. The telemetry unit1006 can be a device that is worn on the skin of the user or can becarried by the user and can have a form similar to a pager, cellularphone, or remote control, if desired. As another alternative, thetelemetry unit 1006 may not be worn or carried by the user but may onlybe available at a home station or at a clinician's office. Theprogramming unit 1008 can be any unit that can provide information tothe telemetry unit 1006 for transmission to the electrical stimulationsystem 1000. The programming unit 1008 can be part of the telemetry unit1006 or can provide signals or information to the telemetry unit 1006via a wireless or wired connection. One example of a suitableprogramming unit is a computer operated by the user or clinician to sendsignals to the telemetry unit 1006.

The signals sent to the processor 1004 via the antenna 1018 and receiver1002 can be used to modify or otherwise direct the operation of theelectrical stimulation system. For example, the signals may be used tomodify the pulses of the electrical stimulation system such as modifyingone or more of pulse duration, pulse frequency, pulse waveform, andpulse strength. The signals may also direct the electrical stimulationsystem 1000 to cease operation, to start operation, to start chargingthe battery, or to stop charging the battery. In other embodiments, thestimulation system does not include an antenna 1018 or receiver 1002 andthe processor 1004 operates as programmed.

Optionally, the electrical stimulation system 1000 may include atransmitter (not shown) coupled to the processor 1004 and the antenna1018 for transmitting signals back to the telemetry unit 1006 or anotherunit capable of receiving the signals. For example, the electricalstimulation system 1000 may transmit signals indicating whether theelectrical stimulation system 1000 is operating properly or not orindicating when the battery needs to be charged or the level of chargeremaining in the battery. The processor 1004 may also be capable oftransmitting information about the pulse characteristics so that a useror clinician can determine or verify the characteristics.

The above specification, examples and data provide a description of themanufacture and use of the composition of the invention. Since manyembodiments of the invention can be made without departing from thespirit and scope of the invention, the invention also resides in theclaims hereinafter appended.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. An implantable lead assembly for providingelectrical stimulation to a patient, the lead assembly comprising: alead body having a proximal end, a distal end, and a longitudinallength; at least one terminal disposed along the proximal end of thelead body; an orthopedic implant coupled to the distal end of the leadbody, the orthopedic implant configured and arranged for anchoring to atleast one bony structure, the orthopedic implant comprising an elongatedorthopedic implant body having a top surface, an opposing bottomsurface, a first end, and an opposing second end, at least one mountingregion disposed along the orthopedic implant body, the at least onemounting region configured and arranged for anchoring the orthopedicimplant to the at least one bony structure, and at least one stimulationregion disposed along the orthopedic implant body; at least oneelectrode disposed along the at least one stimulation region; and atleast one conductor electrically coupling the at least one terminal tothe at least one electrode.
 2. The implantable lead assembly of claim 1,wherein the at least one mounting region comprises a first mountingregion disposed along the first end of the orthopedic implant body and asecond mounting region disposed along the second end of the orthopedicimplant body.
 3. The implantable lead assembly of claim 2, wherein theat least one stimulation region is disposed along the orthopedic implantbody between the first mounting region and the second mounting region.4. The implantable lead assembly of claim 2, wherein the orthopedicimplant body further comprises at least one first mounting aperturedefined along the first mounting region, the at least one first mountingaperture configured and arranged for receiving at least one firstmounting fastener for anchoring the orthopedic implant to the at leastone bony structure; and at least one second mounting aperture definedalong the second mounting region, the at least one second mountingaperture configured and arranged for receiving at least one secondmounting fastener for anchoring the orthopedic implant to the at leastone bony structure.
 5. The implantable lead assembly of claim 4, furthercomprising at least one first mounting fastener configured and arrangedfor passing through the at least one first mounting aperture and foranchoring the orthopedic implant to the at least one bony structure; andat least one second mounting fastener configured and arranged forpassing through the at least one second mounting aperture and foranchoring the orthopedic implant to the at least one bony structure. 6.The implantable lead assembly of claim 1, wherein the at least onestimulation region is arc-shaped.
 7. The implantable lead assembly ofclaim 1, wherein the at least one stimulation region is planar.
 8. Theimplantable lead assembly of claim 7, wherein the at least one mountingregion is planar.
 9. The implantable lead assembly of claim 8, whereinthe at least one mounting region and the at least one stimulation regionextend parallel to one another.
 10. The implantable lead assembly ofclaim 8, wherein the at least one mounting region and the at least onestimulation region extend parallel to one another with the at least onestimulation region disposed beneath the bottom surface of the at leastone mounting surface.
 11. The implantable lead assembly of claim 1,wherein the orthopedic implant body further comprises a transitionregion coupling the at least one mounting region to the at least onestimulation region.
 12. The implantable lead assembly of claim 11,wherein the transition region extends beneath the bottom surface of theat least one mounting surface.
 13. The implantable lead assembly ofclaim 11, wherein the transition region extends in a direction that isnot parallel to either the at least one mounting regions or the at leastone stimulation region.
 14. The implantable lead assembly of claim 1,wherein the at least one electrode is disposed along the bottom surfaceof the at least one stimulation region.
 15. The implantable leadassembly of claim 14, wherein the at least one electrode extendsoutwardly from the bottom surface of the at least one stimulationregion.
 16. The implantable lead assembly of claim 14, wherein the atleast one electrode is inset from the bottom surface of the at least onestimulation region.
 17. An electrical stimulating system comprising: thelead assembly of claim 1; a control module electrically coupled to theat least one electrode of the lead assembly, the control modulecomprising a housing, and an electronic subassembly disposed in thehousing; and a connector assembly for receiving the at least one leadbody of the lead assembly, the connector assembly comprising a connectorhousing defining at least one port at a distal end of the connectorhousing, the at least one port configured and arranged for receiving thelead body of the lead assembly, and at least one connector contactdisposed in the connector housing, the at least one connector contactconfigured and arranged to couple to the at least one terminal disposedalong the lead body of the lead assembly.
 18. A method for implanting alead assembly into a patient, the method comprising: providing the leadassembly of claim 1; and anchoring the at least one mounting region ofthe orthopedic implant of the lead assembly to at least one bonystructure.
 19. The method of claim 18, wherein anchoring the at leastone mounting region of the orthopedic implant of the lead assembly to atleast one bony structure comprises anchoring the orthopedic implant toeach of a first bony structure and a second bony structure.
 20. Theimplantable lead assembly of claim 19, wherein anchoring the orthopedicimplant to each of a first bony structure and a second bony structurecomprises anchoring the orthopedic implant to each of a first bonystructure and a second bony structure with the at least one electrodedisposed between the first bony structure and the second bony structure.